Posted on: Monday, December 31, 2001

FDA looking at safety of kava

By Rita Rubin
USA Today

The Food and Drug Administration is investigating whether popular dietary supplements containing the herb kava — know locally as 'awa — promoted for relief of stress and anxiety, could cause serious liver problems.

Safety concerns first arose in Switzerland and Germany, where 25 to 30 reports of liver toxicity — characterized by jaundice and a variety of other symptoms — were tied to kava products.

Switzerland has banned products containing the kava extract linked to the adverse effects. In Great Britain, where there have been no reports of side effects, makers voluntarily pulled kava products from shelves. According to the British Medicines Control Agency, there were six cases of liver failure reported in kava users in Germany and Switzerland. One person died, four needed liver transplants, and the sixth was being evaluated for a transplant. In some cases, the kava users also were taking other drugs tied to liver problems.

Reporting of side effects is mandatory in Europe but voluntary in the United States. Only in recent years has the FDA heard several reports of health problems in kava users in the United States. This month, the FDA drew up a letter asking healthcare professionals to check whether any patients with liver toxicity may have been using kava.

A coalition of trade groups has hired a toxicologist to review the reported cases.

"One case report here, one case report there does not necessarily constitute a strong body of proof for anything," says Mark Blumenthal, of the American Botanical Council. His group advises against taking kava daily for more than four weeks.

Those who have liver problems, take drugs that affect the liver or drink alcohol regularly should not use it at all.